SINGLE USE GRASPING FORCEPS FG-253SX

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE SUBJECT DEVICE WAS MANUFACTURED IN AUGUST 2023, BUT THE SPECIFIC DATE IS UNKNOWN. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE PACKAGE PRESENTED NO ABNORMALITIES PRIOR TO SHIPPING. THE STERILE PACKAGES THAT ARE ADDITIONALLY HEAT-SEALED HAVE A HIGHER SEAL STRENGTH THAN THOSE THAT ARE NOT ADDITIONALLY HEAT-SEALED AND MAY BE MORE DIFFICULT TO OPEN. THEREFORE, THIS MAY HAVE CAUSED THE REPORTED EVENT. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE OF THE EVENT WAS UNABLE TO BE IDENTIFIED. NO ABNORMALITIES WERE FOUND ON THE SUBJECT DEVICE UPON INSPECTION. THE STERILE PACKAGES THAT ARE ADDITIONALLY HEAT-SEALED HAVE A HIGHER SEAL STRENGTH THAN THOSE THAT ARE NOT ADDITIONALLY HEAT-SEALED. THEREFORE, THE STERILE PACKAGES WITH ADDITIONAL HEAT SEALING ARE DIFFICULT TO OPEN. THEREFORE, THIS MAY HAVE CAUSED THE REPORTED EVENT. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

Description of Event or Problem

A CUSTOMER SUBMITTED A MEDICAL DEVICE INCIDENT OR PROBLEM REPORT (MDIP) TO AHS (ALBERTA HEALTH SERVICES) STATING THE SINGLE USE GRASPING FORCEPS STERILE PACKAGING WAS VERY DIFFICULT TO OPEN. THE PAPER WAS RIPPING WHILE OPENING, CAUSING THE STERILE ITEM TO BECOME CONTAMINATED BEFORE USE. WHILE ATTEMPTING TO OPEN THE FIRST UNIT, THE PACKAGING RIPPED. WHEN THE SECOND UNIT WAS BEING OPENED, THE PACKAGING RIPPED AGAIN, BUT WAS ABLE TO BE OPENED IN A STERILE MANNER AND USED FOR THE SURGICAL PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE. THE CUSTOMER DOUBLE CHECKED TO CONFIRM THE PACKAGING WAS BEING OPENED IN THE CORRECT ORIENTATION. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR PATIENT HARM ASSOCIATED WITH THIS EVENT. RELATED PATIENT IDENTIFIER:(B)(6).

Additional Manufacturer Narrative

TO DATE, THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.